Demitur.

Study characteristics
Methods	A prospective, randomised, controlled, clinical trial Intention‐to‐treat and per‐protocol analyses
Participants	151 participants overall enrolled in the study. Inclusion criteria: Age 0 to 80 years Clinical signs of infarction of the MCA territory with an NIHSS score > 16 for lesions of the non‐dominant hemisphere and > 18 for lesions of the dominant hemisphere Decrease in the level of consciousness to a score of ≥ 1 on item 1a of the NIHSS‐CT or MRI‐DWI showed unilateral MCA infarction, including at least 2/3 of the territory and including at least part of the basal ganglia, with or without additional ipsilateral infarction of the anterior or posterior cerebral artery Onset of symptoms > 12 and < 38 hours before a possible surgical intervention Possibility to start treatment/surgery within 6 hours after randomisation Exclusion criteria: Pre‐stroke mRS score ≥ 2 Pre‐stroke score on the Barthel Index < 95 GCS < 6 Both pupils fixed and dilated Any other coincidental brain lesion that might affect outcome rt‐PA in the 12 hours before randomisation Space‐occupying haemorrhagic transformation of the infarct Pregnancy Life expectancy < 3 years Other serious illness that might affect outcome Known coagulopathy or systemic bleeding disorder Contraindication for anaesthesia
Interventions	Surgical decompression involved a large fronto‐temporo‐parietal ipsilateral hemicraniectomy. Medical therapy for the control group involved intravenous mannitol (0.25 to 0.5 g/kg) or furosemide was given only in participants whose condition was rapidly worsening because of brain oedema, elevation of the head and maintenance of normothermia, normoglycaemia, and normovolaemia. Use of muscle relaxants was left to the discretion of the treating physician and propofol administered as needed. Intravenous antihypertensive agents were recommended when systolic blood pressure was > 220 mmHg or diastolic blood pressure was > 120 mmHg. Prophylaxis of deep venous thrombosis was performed by weight‐adjusted low‐molecular‐weight heparin. If there was no haemorrhagic transformation, antiplatelet or anticoagulant treatment was started 1 week after stroke.
Outcomes	The primary endpoint was survival without severe disability (mRS 0 to 3) at 6 and 12 months. Secondary outcome measures were death, Barthel Index, NIHSS, and quality of life assessed by SIS 2.0 at 6 months and 1 year after randomisation.
Notes	This study was conducted from 2003 to 2008.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "1:1 allocation assignment using a random number table"
Allocation concealment (selection bias)	Low risk	Independent randomisation with codes in sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinding of neurologist assessing primary outcome by placing a surgical cap on the patient
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing data
Selective reporting (reporting bias)	Unclear risk	Study protocol not available Registered on clinical trials registry after study was completed
Other bias	High risk	Study withdrawn soon after publication at the request of the authors. We contacted the authors and the reason given was "conflict between the authors"